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Metal Complex
IV Gallium for Cystic Fibrosis and NTM Infections (ABATE Trial)
Phase 1
Recruiting
Led By Christopher H. Goss, MD, MSc
Research Sponsored by Chris Goss
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Greater than or equal to 18 years of age at Visit 1
Willing to discontinue chronic azithromycin use for the duration of the study
Must not have
Current diagnosis of osteoporosis
History of solid organ or hematological transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 6 to day 111
Awards & highlights
No Placebo-Only Group
Summary
This trial will test the safety of two 5-day cycles of gallium given intravenously to adults with CF who also have an infection with NTM.
Who is the study for?
Adults over 18 with Cystic Fibrosis and NTM infections, who can expectorate sputum and have not been treated for NTM or were treated successfully over 2 years ago. Participants must have a CF diagnosis, two positive NTM cultures from sputum/BAL at least 28 days apart, and be willing to follow the study schedule.
What is being tested?
The trial is testing IV gallium nitrate's safety in adults with Cystic Fibrosis infected by NTM. It involves two cycles of a five-day infusion to evaluate how well patients tolerate this treatment.
What are the potential side effects?
Potential side effects are not detailed here but may include reactions related to intravenous infusions and specific effects of gallium nitrate which will be monitored throughout the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am willing to stop taking azithromycin for the study period.
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I have two known mutations in my CFTR gene.
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I have been diagnosed with cystic fibrosis based on my symptoms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with osteoporosis.
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I have had an organ or bone marrow transplant.
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I have not taken bisphosphonates in the week before starting the trial.
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I haven't used any experimental drugs or joined any clinical trials in the last 28 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 6 to day 111
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 6 to day 111
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse Events of Special Interest
Secondary study objectives
Clinically significant abnormal laboratory measures. (safety)
NTM clearance (efficacy)
Side effects data
From 2018 Phase 2 trial • 119 Patients • NCT0235485948%
Cough
32%
Fatigue
32%
Sputum increased
28%
Headache
20%
Chest discomfort
15%
Sinus congestion
15%
Nausea
13%
Decreased appetite
13%
Dyspnoea
13%
Oropharyngeal pain
12%
Haemoptysis
12%
Pyrexia
10%
Myalgia
10%
Asthenia
10%
Abdominal pain
8%
Nasal congestion
8%
Wheezing
8%
Chest pain
7%
Rash
7%
Pain in extremity
7%
Weight decreased
7%
Rhinorrhoea
7%
Diarrhoea
7%
Paranasal sinus hypersecretion
7%
Pulmonary congestion
7%
Vomiting
7%
Muscle spasms
5%
Pulmonary function test decreased
3%
Contusion
3%
Sinus headache
3%
Constipation
2%
Abdominal pain upper
2%
Night sweats
2%
Arthralgia
2%
Forced expiratory volume decreased
2%
Upper-airway cough syndrome
2%
Dyspnoea exertional
2%
Exercise tolerance decreased
2%
Rales
2%
Distal intestinal obstruction syndrome
2%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gallium
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Infusion of IV GalliumExperimental Treatment1 Intervention
Gallium nitrate will be infused continuously over 5 days at 200 mg/m2/day. Study drug will be administered via a peripheral IV catheter, a peripherally inserted central catheter (PICC) line, midline catheter, or a chronic indwelling vascular access device using an ambulatory infusion pump infused over 24 hours for 5 sequential days for each cycle. There is a maximum of 2 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gallium nitrate
2016
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Chris GossLead Sponsor
4 Previous Clinical Trials
2,230 Total Patients Enrolled
Cystic Fibrosis FoundationOTHER
196 Previous Clinical Trials
37,330 Total Patients Enrolled
Christopher H. Goss, MD, MScPrincipal InvestigatorUniversity of Washington, Seattle Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with osteoporosis.I am currently being treated for NTM disease or will start treatment soon.My health has been stable for the last week.My doctor believes my symptoms are due to NTM disease, despite treatment for other infections.Your blood test results show low levels of hemoglobin, platelets, or neutrophil count, high levels of certain liver enzymes, high serum creatinine, or low ionized calcium.You have repeatedly tested positive for certain types of bacteria in the sputum or lung fluid samples. This means that the same bacteria species has been found in your samples over time, or that you have had multiple positive test results within certain timeframes.You can cough up phlegm.I haven't started any new long-term medications in the last 28 days.I am 18 years old or older.I am willing to stop taking azithromycin for the study period.Your nasal potential difference (NPD) test shows a significant change in response to certain solutions.I am not pregnant, breastfeeding, and I agree to use effective birth control if I can have children.You have had two positive sputum or BAL cultures for NTM bacteria, taken at least 28 days apart.Two positive culture results show the same type of bacteria or microorganism.The sweat chloride level is higher than 60 milliequivalent (mEq)/liter in the sweat test.I have two known mutations in my CFTR gene.You have positive test results for certain types of bacteria called M. avium complex or M. abscessus complex.You have a known allergy to gallium.I have had an organ or bone marrow transplant.I am 18 years old or older.I have been diagnosed with cystic fibrosis based on my symptoms.I have not taken azithromycin in the last 14 days.I have not taken bisphosphonates in the week before starting the trial.I haven't used any experimental drugs or joined any clinical trials in the last 28 days.You have not had any negative test results for NTM since the first of the two positive test results.My NTM infection has either never been treated or was successfully treated over 2 years ago.You are able to breathe out a certain amount of air, as tested during screening.
Research Study Groups:
This trial has the following groups:- Group 1: Infusion of IV Gallium
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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